Prostate Cancer Clinical Trial
Official title:
Effect of Oral Ketoconazole on the Pharmacokinetics of Oral Dexamethasone and Oral Hydrocortisone in Patients With Androgen Independent Prostate Cancer
RATIONALE: Studying samples of blood in the laboratory from patients with cancer receiving
ketoconazole together with dexamethasone and hydrocortisone may help doctors learn more
about how these drugs are used by the body.
PURPOSE: This randomized clinical trial is studying how ketoconazole, dexamethasone, and
hydrocortisone act in the body of patients with prostate cancer that did not respond to
androgen-deprivation therapy.
OBJECTIVES:
- To evaluate the pharmacokinetics of oral dexamethasone with and without oral
ketoconazole in patients with androgen-independent prostate cancer.
- To compare the pharmacokinetics of oral hydrocortisone with and without oral
ketoconazole in these patients.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral dexamethasone twice daily on days 1-14, oral ketoconazole
3 times daily on days 2-14 and 30-42, and oral hydrocortisone twice daily on days
29-42.
- Arm II: Patients receive oral hydrocortisone twice daily on days 1-14, oral
ketoconazole 3 times daily on days 2-14 and 30-42, and oral dexamethasone twice daily
on days 29-42.
In both arms, patients may receive ketoconazole and hydrocortisone as standard salvage
therapy off study.
In both arms, patients undergo blood sample collection on days 1, 14, 29, and 42 for
pharmacokinetic studies.
;
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
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